Obesity Treatments to Improve Type 1 Diabetes. The OTID trial Protocol for obesity treatments to improve Type 1 Diabetes. The OTID trial

Abstract

• Background The guidelines of the American Diabetes Association and European Association for the Study of Diabetes suggest that patients with obesity type 2 diabetics, and chronic kidney disease need either glucagon-like peptide 1 receptor analogues or sodium-glucose cotransporter-2 inhibitors. If neither achieve metabolic control, then the recommendation is to combine both drugs. The evidence base for combining glucagon-like peptide 1 receptor analogues and sodium-glucose cotransporter-2 inhibitors are not well researched, and hence the impact of the guidelines are limited. The aim of this randomized controlled trial is to test the impact of the combination of glucagon-like peptide 1 receptor analogues / sodium-glucose cotransporter-2 inhibitors on body weight and kidney damage, in patients with type 1 diabetes and chronic kidney disease. In addition, we will explore associated changes in metabolic pathways with each of the treatments used in this randomized controlled trial. • Methods In this 6-month randomized control trial, 60 participants aged between 21–65 years, with a body mass index above 25kg/m2 and type 1 diabetics with chronic kidney disease will be randomized to receive one of five possible treatments 1) Standard care (control), 2) glucagon-like peptide 1 receptor analogues alone, 3) sodium-glucose cotransporter-2 inhibitors alone, 4) combination of glucagon-like peptide 1 receptor analogues and sodium-glucose cotransporter-2 inhibitors, 5) combination of glucagon-like peptide 1 receptor analogues and sodium-glucose cotransporter-2 inhibitors with intensive lifestyle advice. The primary objective will be the percentage change in total body weight from baseline at 6 months. The secondary objectives are to compare change in glycaemia, blood pressure, dyslipidaemia, albuminuria, proportion of participants reaching weight loss of ≥ 5%, ≥ 10% and ≥ 15%, change in BMI (kg/m2) from baseline and change in waist circumference (cm). All the experiments will be conducted at the Dasman Diabetes Institute after approval from the local research and ethics committee. • Discussion The present randomized controlled trial aims to investigate the impact of the combination of glucagon-like peptide 1 receptor analogues and sodium-glucose cotransporter-2 inhibitors on body weight and kidney damage in patients with type 1 diabetes mellitus and chronic kidney disease, as well as exploring associated changes in metabolic pathways with each of the treatments used. This study addresses the current gap in the evidence base regarding the combination of these two drugs, which is particularly relevant given the American Diabetes Association and European Association for the Study of Diabetes guidelines recommending their combined use for patients with obesity, type 2 diabetes, and chronic kidney disease who do not achieve metabolic control with either drug alone. Trial registration ClinicalTrials.gov Identifier: NCT0539030